Back to resultsOpen Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
Primary Purpose
Depression
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, chronic renal failures, end stage renal disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic renal failure and end stage renal disease
- Ongoing need for regular dialysis treatment
- Diagnosis of depression based on DSMIV
- Age tween 19-65 years
Exclusion Criteria:
- Inability to provide informed consent
- Medically or psychiatrically unstable, as defined by requiring inpatient treatment
- Pregnancy, nursing or refusal to use a reliable method of birth control in women
- Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
Sites / Locations
- Creighton Department of Psychiatry
- Creighton University Department of Psychiatry
Outcomes
Primary Outcome Measures
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
Secondary Outcome Measures
Full Information
NCT ID
NCT00573547
First Posted
December 12, 2007
Last Updated
August 15, 2011
Sponsor
Creighton University
1. Study Identification
Unique Protocol Identification Number
NCT00573547
Brief Title
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
Official Title
A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator decided not to initiate the study.
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.
Detailed Description
Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, chronic renal failures, end stage renal disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Fluoxetine will be dosed at 90 mg once a week
Primary Outcome Measure Information:
Title
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
Time Frame
Patients will come in for once weekly visits for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic renal failure and end stage renal disease
Ongoing need for regular dialysis treatment
Diagnosis of depression based on DSMIV
Age tween 19-65 years
Exclusion Criteria:
Inability to provide informed consent
Medically or psychiatrically unstable, as defined by requiring inpatient treatment
Pregnancy, nursing or refusal to use a reliable method of birth control in women
Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed P Sattar, MD
Organizational Affiliation
Creighton University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton Department of Psychiatry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Creighton University Department of Psychiatry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease
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